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Intensified treatment in patients with oligometastatic pancreatic cancer - multimodal surgical treatment versus systemic chemotherapy alone: a randomized controlled trial - METAPANC
EU CTIS ID: 2023-503558-10-00
What this study is testing
Is the overall survival in patients with oligometastatics pancreatic cancer superior in patients treated with perioperative mFOLFIRINOX-followed by complete surgical resection compared to standard-of-care mFOLFIRINOX first-line chemotherapy alone.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years and ≤ 80 years
- histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
- medical and technical operability of the primary tumor
- limited synchronous liver metastatic status (≤3 resectable/ablatively treatable liver metastases) OR limited metachronous liver metastatic status (≤3 resectable/ ablatively treatable liver metastases), but must have completed adjuvant chemotherapy at least 6 months before start of study treatment
- Previous neo-/adjuvant anti-cancer therapy for non-metastatic PDAC with last dose administered ≥6 months before the start of study treatment are allowed
- adequate hematological (WBC ≥3000/µl, platelets ≥100.000/µl, hemoglobin ≥8 g/dl), hepatic (bilirubin ≤2.5 x mg/dl) and renal function (creatinine clearance >50 ml/min) parameters
You likely can't join if
- Unresectable pancreatic cancer
- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly)
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. These conditions should be discussed with the patient before registration in the trial.
- Prior chemotherapy within 6 months or prior radiation therapy within 28 days (e.g. in adjuvant settings). Exception for previous systemic anti-cancer treatment for metastatic PDAC: Patients with need of immediate treatment (high tumour load, symptoms) may have received one cycle of FOLFIRINOX or modified FOLFIRINOX prior to study entry (Cycle 0) and may be enrolled after Coordinating Investigator approval has been obtained.
- Concurrent malignancy other than the disease under investigation with exception of malignancy that was treated curatively and has not recurred within 2 years prior to the date of screening. Fully resected basal or squamous cell skin cancers and any carcinoma in situ are eligible
- Patients with either peritoneal carcinomatosis or >3 liver metastases or extrahepatic metastasis)
See the full eligibility criteria
Who can join
- Age ≥ 18 years and ≤ 80 years
- histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas
- medical and technical operability of the primary tumor
- limited synchronous liver metastatic status (≤3 resectable/ablatively treatable liver metastases) OR limited metachronous liver metastatic status (≤3 resectable/ ablatively treatable liver metastases), but must have completed adjuvant chemotherapy at least 6 months before start of study treatment
- Previous neo-/adjuvant anti-cancer therapy for non-metastatic PDAC with last dose administered ≥6 months before the start of study treatment are allowed
- adequate hematological (WBC ≥3000/µl, platelets ≥100.000/µl, hemoglobin ≥8 g/dl), hepatic (bilirubin ≤2.5 x mg/dl) and renal function (creatinine clearance >50 ml/min) parameters
- ECOG performance status ≤1
- Written informed consent obtained according to international guidelines and local laws
- measurable disease according to RECIST v1.1. prior to induction therapy
What rules you out
- Unresectable pancreatic cancer
- Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly)
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. These conditions should be discussed with the patient before registration in the trial.
- Prior chemotherapy within 6 months or prior radiation therapy within 28 days (e.g. in adjuvant settings). Exception for previous systemic anti-cancer treatment for metastatic PDAC: Patients with need of immediate treatment (high tumour load, symptoms) may have received one cycle of FOLFIRINOX or modified FOLFIRINOX prior to study entry (Cycle 0) and may be enrolled after Coordinating Investigator approval has been obtained.
- Concurrent malignancy other than the disease under investigation with exception of malignancy that was treated curatively and has not recurred within 2 years prior to the date of screening. Fully resected basal or squamous cell skin cancers and any carcinoma in situ are eligible
- Patients with either peritoneal carcinomatosis or >3 liver metastases or extrahepatic metastasis)
- Known hypersensitivity to the active substances or any of the excipients
- Impaired cardiac function or clinically significant cardio-vascular disease, such as: – Congestive heart failure requiring treatment (NYHA grade >2), or clinically significant arrhythmia (including uncontrolled atrial flutter/fibrillation) – Acute myocardial infarction, unstable angina pectoris, coronary stenting, or bypass surgery < 3 months prior to study entry
- Simultaneous participation in other interventional trials which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
- Inability to understand the study and/or comply with the protocol procedures
- Subject pregnant or breast feeding, or planning to become pregnant within 6 months
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.